FDA UDI
In Commercial Distribution
🇺🇸 United States
ClearChem Diagnostics Inc. Total Bilirubin
DI: 00852169008317
·
Model: BRB212
·
CLEARCHEM DIAGNOSTICS INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ClearChem Diagnostics Inc. Total Bilirubin
- Primary DI
- 00852169008317
- Version / Model
- BRB212
- Company Name
- CLEARCHEM DIAGNOSTICS INC.
- Labeler DUNS
- 010655581
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-01-20
- Public Version
- 1
- Public Version Date
- 2023-01-30
- Public Version Status
- New
- Public Device Record Key
- 8b2bef5e-d0fc-4514-abd6-5440ab92cb3e
Device Description
In Vitro Diagnostics testing kit R1C: 4X52.5mL, R1B: 4X52.5mL
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | Clinical Chemistry | 862.1110 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 53231 | Total bilirubin IVD, reagent | A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of total bilirubin in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00852169008317 | GS1 |
Customer Contacts
- Phone
- 7147348041
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 420 | Milliliter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius